eTMF

Flex Databases eTMF is a comprehensive Electronic Trial Master File solution designed for clinical trial teams, CROs, sponsors, and biotech organisations that need complete, real-time visibility into their trial documentation. The platform enables secure, 24/7 access to all trial files from anywhere in the world, supporting inspection readiness as a continuous, daily state rather than a last-minute effort.

Built for the demands of modern clinical operations, Flex Databases eTMF combines intuitive document management with AI-powered automation, deep integration capabilities, and robust compliance features — all without requiring excessive user training.

Dashboard and Visibility

• Instant, secure access to trial documentation from any location at any time.
• Real-time statistics on folder completeness, missing documents, and file upload progress, filterable by milestone or other parameters.
• Automated to-do lists, flexible widgets, and exportable reports to keep teams focused on the most relevant tasks.
• Business Intelligence tools including ad-hoc cross-project and cross-module reporting, and a powerful search engine that queries both file names and document content.

Document Upload and Daily Workflow Tools

• Multiple upload methods: email a document directly into eTMF, use the mobile app, drag and drop, connect via WebDAV as an external drive, or browse and upload through the browser.
• Automated filing of documents from the integrated CTMS module, requiring zero manual effort.
• eTMF Manager space for reviewing, assigning metadata, and distributing documents to the correct folders in one place.
• Bulk document sending to sites directly from eTMF via email, with a full track record maintained.
• Embedded eSignature functionality supporting document review, approval, locking, signing, and authoring workflows.
• Online viewing and authoring via browser without the need to download files.
• OCR capability that recognises text within pictures, scans, and photos.

AI-Powered Document Filing

• AI automatically assigns correct metadata to documents, ensuring accurate and compliant filing.
• AI processes documents continuously as soon as they are uploaded, eliminating manual metadata assignment delays.
• AI runs on separate, local servers within the user's region (EU, US, or elsewhere) — never in the public cloud — with encrypted connections and dedicated processing queues to ensure data privacy and security.
• Thorough validation support is provided, including validation of the AI models themselves for guaranteed regulatory compliance.

Quality Review and Inspection Readiness

• Periodic eTMF review is simplified through the My Views tab, which allows users to define custom document lists based on metadata groups and use an inbuilt chat function to query and correct documents.
• QC Workflow available for all file types, folders, and placeholders.
• Chat and comments available at both document and folder level.
• Configurable document review, approval, locking, and signing workflows with electronic signature support.
• Adjustable notifications and alerts, including metadata-triggered actions such as notifications on document expiry dates.

Compliance and Security

• 21 CFR Part 11 compliant.
• GDPR-compliant.
• Full audit trail and document versioning.
• Flexible access control matrix based on project role, sites, folders, countries, and for external users such as inspectors, auditors, and partners.
• Easy archiving of eTMF projects with index and audit trail included.
• Fully validated system with all related validation documentation provided.

Metadata Management

• Custom metadata setup and management with various metadata structure templates available.
• Support for the DIA Reference Model in TMF template creation and configuration.
• Metadata actions such as automated notifications on document expiry dates.
• Dynamic metadata reports for ongoing oversight.

Technical Capabilities and Integrations

• Web-based platform requiring no installation.
• Available as both cloud-hosted and on-premise deployments.
• Single sign-on (SSO) functionality via LDAP and SAML protocols.
• Bidirectional API available for integrations with third-party systems.
• Microsoft 365 collaboration support for streamlined document co-authoring and version management.
• Duplicate detection with real-time scanning on upload, checking both file name and document content.
• Recognises special and foreign characters.
• Mobile application for on-the-go access.

Flex Databases eTMF is trusted by over 100 clients across 30+ countries, supporting more than 2,000 clinical trials and 20,000 daily users managing over 10 million documents. The platform is suitable for organisations of all sizes seeking a validated, inspection-ready eTMF that integrates seamlessly with broader clinical trial management workflows.